John M. Email & Phone Number

Lawrenceville, Ga, Us

United States

Marietta, Georgia, United States

Gainesville, Florida Area

Oversight of the Quality Management System in the company specially within the Engineering/Validation activities and supervise the Quality Engineering Team.

Gainesville, Florida Area

Responsible for maintaining the Quality Manage System as established by procedures. Reviewer and Approver of Change Controls and Deviations in Trackwise System.Reviewer and Approver of Validation Protocols, pre approvals, deviations, executions and Reports post execution approvals.Review and approve Standard operating procedures for the manufacturing and laboratory equipment and utilities. Participate and conduct meetings for Validations projects, defining… Show more Responsible for maintaining the Quality Manage System as established by procedures. Reviewer and Approver of Change Controls and Deviations in Trackwise System.Reviewer and Approver of Validation Protocols, pre approvals, deviations, executions and Reports post execution approvals.Review and approve Standard operating procedures for the manufacturing and laboratory equipment and utilities. Participate and conduct meetings for Validations projects, defining project plans, deliverables and give support to personnel involved. Show less

Manati, Pr, Puerto Rico

Brystol Myers Squibb ProjectValidation Specialist, responsible for the development, tracking and execution of the Validation Protocols for the PVA Cell 2 expansion project such as Facilities, HVAC and non-GMP Utilities (Fire Alarm, Data Security Communication, Potable Water, etc). These activities include and are not limited to:▪ Validation of the Fire Alarm / Fire Protection System.● Site Acceptance Test (SAT) Protocol development and execution.▪ Validation of the New… Show more Brystol Myers Squibb ProjectValidation Specialist, responsible for the development, tracking and execution of the Validation Protocols for the PVA Cell 2 expansion project such as Facilities, HVAC and non-GMP Utilities (Fire Alarm, Data Security Communication, Potable Water, etc). These activities include and are not limited to:▪ Validation of the Fire Alarm / Fire Protection System.● Site Acceptance Test (SAT) Protocol development and execution.▪ Validation of the New Facilities at the PVA Cell 2 Expansion Project.● Site Acceptance Test (SAT) Protocol development and execution.▪ Validation of the New HVAC System● Site Acceptance Test (SAT) Protocol development and execution for new AHU-5000.● Site Acceptance Test (SAT) Protocol development and execution for new AHU-5001.▪ Computer System Validation for Delta V new servers installation.● Installation and Operational Protocol development and execution.● Traceability Matrix update and approval.Other responsibilities include and are not limited to:● Participate and develop FMEA document for each validation project.● Develop and/or review LifeCycle Documents such as: URS, Traceability Matrix, etc.● Develop and track Validation Discrepancies, Deviations and Report approvals. Show less

Manati, Pr, Puerto Rico

Computer System Validation Specialist, responsible for the development, tracking and execution of the Validation Protocols for projects such as Carbon Bed Adsorber, Bin Blender, Quadro Comil Milling System, etc. These activities include and are not limited to:▪ Validation of the Carbon Bed Adsorber due to a Hydrocarbon Analyzer installation.● Installation, Operational and CSV Qualification Protocol development and execution.▪ Validation of the Servolift Bin… Show more Computer System Validation Specialist, responsible for the development, tracking and execution of the Validation Protocols for projects such as Carbon Bed Adsorber, Bin Blender, Quadro Comil Milling System, etc. These activities include and are not limited to:▪ Validation of the Carbon Bed Adsorber due to a Hydrocarbon Analyzer installation.● Installation, Operational and CSV Qualification Protocol development and execution.▪ Validation of the Servolift Bin Blender● Installation, Operational and CSV Qualification Protocol development and execution.▪ Validation of the Quadro Comil Milling System● Installation, Operational and CSV Qualification Protocol development and execution.Other responsibilities include and are not limited to:● Participate and develop FMEA document for each validation project.● Develop and/or review LifeCycle Documents such as: URS, Traceability Matrix, etc.● Develop and track Validation Report approvals. Show less

Guayama, Pr

Validation of Computer System and processes in the Packaging and Manufacturing Areas.

Baxter, Guayama

Serialization of Fill and Pack Products

Puerto Rico

TEVA Active Product Ingridients (TAPI) - Guayama site

Crimping Machine Software Validation at Boston Scientifics, Dorado Site.

Amgen, Juncos Aml7

Commissioning and Qualification activities. Transfer Product Project.

Alarms Assessment and Remediation Project

Pfizer Pch Guayama, Pr

Validation and Qualification of Critical Utilities and Equipment in the Weight, Dispense, Compression and Coating Areas. Purified Water and Compressed Air Points of use Validation Protocols development and execution. GMP Equipments Qualification protocols development and execution..

Arecibo, Pr

Lean Six Sigma Greenbelt Proyect in API Coating Area of Janumet XR manufacturing production. SOP review of the discharge tasks in order to improve the overall process time. Brainstorming, time data collection and Minitab statistic work.

Bachelor Degree Graduate, Chemical Engineering

Education record

High School Graduate, High School/Secondary Diplomas And Certificates